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TICACOS International (P2 -RMCS)

21. november 2013 opdateret af: Pierre singer, Rabin Medical Center

Tight Caloric Balance in ICU Patients: a Multicenter, Prospective, Randomized, Controlled Study.

The aim of this study is to perform a prospective, randomized, controlled blinded study in critically patients to assess the necessity for measuring daily resting energy expenditure as a guide for nutritional support. Our hypothesis is that tight caloric control will reduce the rate of new infections.

Study Design :Multi-center, randomized, single blinded, controlled study. Study Population: newly-admitted, adult mechanically ventilated ICU patients.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study objectives

To evaluate the effect of tight caloric control in critical patients on:

  • The rate of acquired nosocomial infections (Ventilated associated pneumonia, Catheter related infections, Urinary tract infections)
  • Mortality rates, length of stay in the ICU and in hospital, length of ventilation and incidence of non-infectious complications.

Primary endpoint:

Rate of nosocomial infections (for definitions see appendage 1) acquired after 48 to 72 hours following admission.

Secondary endpoints

  • Metabolic control: glucose concentration, insulin administration, rate of hypoglycemic events.
  • Success of tight caloric control: accumulative and maximum negative energy balance.
  • Organ function: SOFA score.
  • Rate of non-infectious complications: requirement for surgery or occurrence of pressure sores.
  • Length of ICU stay and of assisted ventilation (LOS and LOV)
  • ICU survival rate.
  • Patient status and disposition on day 28 or at hospital discharge.
  • 3 & 6 months survival.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

560

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Israel
      • Petach Tikva, Israel, 49100
        • Rekruttering
        • Rabin Medical Center, Campus Beilinson
        • Kontakt:
        • Underforsker:
          • Ronit Anbar, RD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Mechanically-ventilated adults(Male or Female)admitted to general ICU within the first 48 hours of ICU admission.
  2. Age ≥ 18 years;no upper age limit.
  3. Expected stay in ICU> 3 days: [SAPS II (18) > ICU median or high-level of nursing care implemented or per clinical impression of attending physician]
  4. Medical and abdomino/thoracic surgery patients, as well as multiple trauma patients with Glasgow Coma Score ≥ 10.

Exclusion Criteria:

  1. Pregnancy.
  2. DNR order.
  3. Readmission in the ICU during the same hospitalization/transfer from other ICU.
  4. Admission for postoperative monitoring.
  5. Respiratory instability: SpO2 <90% or need for ventilator adjustments during the preceding hour or hyperventilation (Respiratory rate > 35/min)
  6. Bicarbonate infusion, loss of bicarbonate (diarrhea, ureterosogmoidostomy or use of acetazoloamide, ultrafiltration).
  7. Aerosolization with nitric oxide or heliox, tracheal insufflations or visible leaks in chest drainage system.
  8. FiO2 80% or patients requiring prone position
  9. Chronic/acute liver failure:Child-Pugh class C
  10. Brain injury for various reasons with Glasgow Coma Scale below 10.
  11. Cardiac surgery patients.
  12. Patients in the hospital for more than 7 days.
  13. Contra indication to use enteral nutrition.
  14. Participation in a clinical study with an investigational drug within one month prior to the start of this clinical trial.
  15. Ethical issues that will influence subject eligibility.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control group
Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the "liberal " regimen, i.e. according to local practice.
Eksperimentel: Indirect Calorimetry
Study group: Indirect Calorimetry (IC) Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry measurement of Resting Energy Expenditure (REE).
Kosttilskud: Indirect Calorimetry measurement of Resting Energy Expenditure .
Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rate of nosocomial infections
Tidsramme: After 48 to 72 hours /daily assessment: within 28 day
Rate of nosocomial infections acquired after 48 to 72 hours following admission up to day 28/or discharge will be evaluated
After 48 to 72 hours /daily assessment: within 28 day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Metabolic control
Tidsramme: Day 1 up to day 28/or discharge
Glucose concentration, insulin administration, rate of hypoglycemic events will be daily assessed
Day 1 up to day 28/or discharge
Caloric control
Tidsramme: Day 1 up to day 28/or discharge
Success of tight caloric control:accumulative and maximum negative energy balance
Day 1 up to day 28/or discharge

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rabin Medical Center

Samarbejdspartnere

Baxter Healthcare Corporation

Efterforskere

  • Ledende efterforsker: Pierre Singer, MD, Professor, RabinMC,Beilinson Hospital
  • Studieleder: Milana Grinev, RN,Study Coordinator, RabinMC, Beilinson Hospital ,Petah- Tikva, Israel

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2011

Primær færdiggørelse (Forventet)

1. december 2014

Studieafslutning (Forventet)

1. december 2014

Datoer for studieregistrering

Først indsendt

22. november 2011

Først indsendt, der opfyldte QC-kriterier

23. november 2011

Først opslået (Skøn)

24. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. november 2013

Sidst verificeret

1. november 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 4329

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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